MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS- menthol lozenge

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops by

Drug Labeling and Warnings

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops by is a Otc medication manufactured, distributed, or labeled by Xiamen Kang Zhongyuan Biotechnology Co., Ltd., Medical Group Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each lozenge)

Menthol 5.4 mg

Purposes

Cough suppressant/oral anesthetic

Uses

temporarily relieves:
cough due to a cold  occasional minor irritation, pain, sore mouth, and sore throat

Warnings

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have
a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough accompanied by excessive phlegm (mucus)

When using this productdo not exceed recommended dosage

Stop use and ask a doctor if
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens

Keep this and all drugs out of the reach of children.

Directions

adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
children under 2 years of age: ask a doctor

Other information

store at room temperature.
keep away from excessive heat or sunlight
do not use if primary bag seal has been torn or broken.
contains: SOY

Inactive ingredients

citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, water.

Questions or comments?

Call +1-866-306-9136
You may also report concerns to this phone number
Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us

SPL UNCLASSIFIED SECTION

RESEALABLE BAG

COMPARE TO ACTIVE INGREDIENT OF HALLS ®

MENTHOL FLAVOR

√ SOOTHING DROPS
√ GLUTEN FREE
√ DAIRY FREE

CLOSE BAG TO MAINTAIN FRESHNESS

DISTRIBUTED BY: 
MEDICAL GROUP CARE, LLC
NAPLES, FL 34110

MADE IN CHINA

This product is not manufactured or distributed by
Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®

Contains 12 calories per lozenge
customerservice@mgc.us

CHOKING HAZARD:
SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.
CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

Packaging

INGREDIENTS AND APPEARANCE

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83698-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	21mm
Flavor	MENTHOL	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83698-110-30	30 in 1 BAG; Type 0: Not a Combination Product	06/21/2024
2	NDC: 83698-110-80	80 in 1 BAG; Type 0: Not a Combination Product	06/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/21/2024

Labeler - Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (411759931)

Registrant - Medical Group Care LLC (085137089)